At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

Job Function:

Regulatory Affairs Group

Job Sub Function:

Regulatory Affairs

Job Category:

Professional

All Job Posting Locations:

Horsham, Pennsylvania, United States of America, Malvern, Pennsylvania, United States of America, Raritan, New Jersey, United States of America, Spring House, Pennsylvania, United States of America, Titusville, New Jersey, United States of America

Job Description:

About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at https://www.jnj.com/innovative-medicine

Johnson & Johnson Innovative Medicine R&D is recruiting for a Lead Regulatory Scientist - Oncology. This position can be located in Raritan, NJ; Titusville, NJ; Spring House, PA; Horsham, PA; or Malvern, PA.

This position will support the North American Regulatory Leader (NARL) and/or Global Regulatory Leader (GRL) for regulatory activities for compounds in development and/or marketed products in the assigned portfolio within the Oncology therapeutic area.

Principal Responsibilities:

• Participate in global regulatory team meetings and provide advice the applicable regulatory requirements, project-specific regulatory issues.

• Build an understanding of the regional regulatory environment (relevant laws, regulations, guidance and competitive landscape) for assigned products.

• Assist in strategy development by researching regulatory and medical information in preparing submissions to North American Health Authorities (HAs).

• Assist in the preparation of HA meetings and act as back-up for contact with HA as needed.

• Ensure responses to HA queries are made in a timely manner, and that content is consistent with the regulatory strategy.

• Provide regulatory support throughout registration process and life-cycle management.

• Work cross-functionally and lead team meetings as appropriate.

• Review development plans, protocols and submission plans, ensuring alignment with regulatory requirements.

• Support the development and improvement of processes related to regulatory submissions.

• Stay on top of current and pending approvals in specific therapeutic areas and knowledgeable of laws, guidances and requirements related to those areas.

Qualifications:

• A minimum of a Bachelor’s degree in a scientific or related discipline is required. Advanced degree (Master’s, PharmD, Ph.D.) preferred.

• A minimum of 6 years of relevant industry experience with a Bachelor’s degree; a minimum of 4 years of relevant industry experience with a Master’s degree; or a minimum of 2 years of relevant industry experience with a PharmD/Ph.D. degree is required.

• Previous regulated health industry experience is required.

• Direct experience in regulatory affairs is preferred.

• Solid understanding of the drug development process and regulatory submission and approval processes is required.

• Knowledge of U.S. guidelines and practices in the regulatory environment is required.

• Oncology drug development experience is preferred.

• Regulatory, Clinical or R&D experience with products in early and late development stages preferred.

• Experience responding to FDA requests, handling Health Authority interactions, and lifecycle management of regulatory applications is preferred.

• Project management experience is required.

• Must have excellent communication and interpersonal skills.

• Must have strong organization, multi-tasking and time management skills.

• Must have effective critical thinking skills, including problem-solving and goal setting for improved efficiencies, and contingency planning skills with respect to organizational or program objectives.

• The ability to collaborate effectively with all levels within a cross-functional environment is required.

• The ability to influence or persuade others within area of immediate responsibility, scope and level to accept new insights, practices and approaches is required.

• This position will require up to 10% travel.

The anticipated base pay range for this position in all other U.S. locations is $105,000 to $169,050.

The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/ performance year. Bonuses are awarded at the Company’s discretion on an individual basis.

Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.

Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).

Employees are eligible for the following time off benefits:

• Vacation - up to 120 hours per calendar year

• Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year

• Holiday pay, including Floating Holidays - up to 13 days per calendar year

• Work, Personal and Family Time - up to 40 hours per calendar year

For additional general information on company benefits, please go to: https://www.careers.jnj.com/employee-benefits

The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.

This job posting is anticipated to close on April 15, 2025. The Company may however extend this time-period, in which case the posting will remain available on https://www.careers.jnj.com to accept additional applications.

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

The anticipated base pay range for this position is:

The anticipated base pay range for this position in all other U.S. locations is $105,000 to $169,050.

Additional Description for Pay Transparency:

The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/performance year. Bonuses are awarded at the Company’s discretion on an individual basis. Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Company’s long-term incentive program. Employees are eligible for the following time off benefits: Vacation – up to 120 hours per calendar year Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year Holiday pay, including Floating Holidays – up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year Additional information can be found through the link below. http://www.careers.jnj.com/employee-benefits The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.

Push the boundaries of science to transform health—and your career.

Join us and advance life-changing treatments for people who need them most. At Johnson & Johnson, our focus is on improving global health equity and developing MedTech and pharmaceutical innovations that impact the future of health. Using AI and robotics to transform surgery or helping data scientists and clinicians formulate new ways to diagnose and treat disease, this work may sound like sci-fi, but it’s all science, all real, and could be your career. Whatever your background, skills, or career goals, there’s a place for you to help solve some of the world’s most pressing health challenges with us.

Accelerate your career while changing the world.

Each of our broadly-based family of companies offers an inclusive and empowering culture and employee benefits (like paid time off to volunteer, transgender-inclusive and same-sex partner health insurance coverage, and more) designed to help you live your best life, however you define it. And our best-in-class learning and development approaches, mentorship, and access to innovators across the world will help you grow your skills and reach your career goals. Because when you're at your best, nothing stands between you and your next breakthrough.